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Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…
Thermal Analysis, Finite Element, SINDA
All models start from simple schematic models. The simple model has as few nodes as possible in order to capture important features and gain insight. Complexity is added to the models until the desired refinement and accuracy is obtained. The…
Electronic and Mechanical Device Reliability, Failure Analysis, Risk and Safety Assessment
Expert is an expert in the fields of reliability, risk, and safety assessment. He performs electronic and mechanical device reliability analysis, failure analysis, failure modes and effects analysis, and fault tree analysis. Expert is an expert in the fields of…
Expert in Patent Litigation, Telecommunication Industry; Communications Systems: Wireless, Data and TV
Expert is a 53-year veteran of the electronics and telecommunications industry. Most recently, he provides operations management and technical services to the telecommunications industry. He specializes in wireless data and television communications systems. Services he provides to clients include operations…
Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Display Materials, Lamp Materials, Electronic Materials (Powders, Thin Films, Nano) and Solar Cells
Expert is a multidiscipliarian managing development & commercialisation from start-ups to sales in electronic displays, lamps & electronic materials. He has spent nearly a decade developing hot, cold & sintered cathodes for gas discharge lamps including use in signage, automotive…
Reliability Engineering; Robot & Medical Device Reliability & Safety; Human Reliability
Expert S. Expert has worked for a number of years in this industry. Over the years, he has developed many techniques and models to predict the reliability and safety of engineering systems including computers, mechanical equipment, robotic systems, and electrical…
Automated Chemical Sensors
LABORATORY COMPUTERIZED ANALYTICAL INSTRUMENTATION DESIGN; CHEMICAL AUTOANALYSIS. Expert has spent much of his career developing systems or subsystems for devices accomplishing automated chemical analysis. He has experience in all phases of this process, from basic research into sensors to the…